Beruflich Dokumente
Kultur Dokumente
Allergen Management
and Labelling
edit
d
e
s
i
v
e
r
007
ion
Contents
1. Introduction
1.1 Statutory Requirements
1.2 Cross contact allergens
3
3
4
3. Allergen Management
3.1 Training and supervision
3.2 Raw materials
3.3 Premises
3.4 Storage and distribution
3.5 Manufacturing process
3.6 Rework
3.7 Filling and packing
3.8 Equipment and line design
3.9 Cleaning
3.10 Formulation and labelling controls
5
6
6
7
7
7
7
8
8
8
8
5. Labelling
5.1 Foods that must be labelled
5.2 Industry responsibilities
5.3 Allergen labelling declaration
5.4 General allergen labelling recommendations
5.5 Recommended Labelling Format
5.6 Recommended Labelling Alternatives
9
9
10
10
10
11
12
14
14
15
15
Food Industry Guide to Allergen Management and Labelling - 2007 Revised Edition
Liability Statement
The guidance, procedures and risk management tools contained in this document are intended to
provide industry best practice in the management and labelling of allergenic foods and ingredients
regulated by the Australia New Zealand Food Standards Code.
The user needs to apply their own skills, knowledge and experience and identify any additional risks
associated with the intended consumer group, in applying VITAL to their specific manufacturing
environment. If necessary, the user should undertake appropriate training to implement this
guidance.
VITAL may be updated over time as further scientific knowledge in relation to allergens and
reactions becomes available. It is the responsibility of the user to keep informed of such
developments, accessible on the Allergen Bureau website.
The user acknowledges that the Australian Food and Grocery Council, its employees, committee
and working group members and agents, accept no liability (including as a result of negligence) for
any loss, injury or death that may result from the consumption of a product labelled using VITAL.
1. Introduction
This guide has been prepared by the Australian Food and Grocery Council Allergen Forum and
is supported by the New Zealand Food & Grocery Council and replaces the 2002 edition. The
Guide is relevant to all sectors of the food industry involved in the supply, handling, production,
distribution and sale of foods. It provides recommendations for the production and labelling of
foods containing allergenic substances as defined in the Australia New Zealand Food Standards
Code (the Code).
This guide is supported by the Allergen Bureau and by additional resources and information
available on the Allergen Bureau website. Please check the Allergen Bureau website for detailed
information and the latest updates - (http://www.allergenbureau.net/).
This guide provides:
an overview of the requirements outlined in the Code regarding food allergens that require
labelling
an overview of the incidence and symptoms of food allergy and food intolerances and the
substances in food that may provoke allergic reactions
guidance on the control and management of allergens in the manufacture of foods
information on testing for allergens
guidelines for declaring mandatory and voluntary allergen information for foods
an outline of VITAL (Voluntary Incidental Trace Allergen Labelling).
1.1
Statutory Requirements
Food Standards Australia New Zealand (FSANZ) provides a consolidated version of the Code on
their website - (http://www.foodstandards.gov.au/thecode/foodstandardscode.cfm).
Standard 1.2.3 of the Code specifies requirements for the mandatory declaration of certain
substances and their products. For most packaged foods, the information must appear on
the label. In other cases, the information must be shown with the food display or provided to
consumers on request.
The substances which must be declared are:
cereals containing gluten and their products, namely, wheat, rye, barley, oats, spelt and
their hybridised strains other than where these substances are present in beer and spirits
standardised in Standards 2.7.2 and 2.7.5 respectively
crustacea and their products
egg and egg products
fish and fish products
milk and milk products
peanuts and soybeans and their products
added sulphites in concentrations of 10 mg/kg or more
tree nuts and sesame seeds and their products.
Food Industry Guide to Allergen Management and Labelling - 2007 Revised Edition
This declaration applies when the listed products are present as:
an ingredient; or
an ingredient of a compound ingredient; or
a food additive or a component of a food additive; or
a processing aid or a component of a processing aid.
Schedule 4 to Standard 1.4.2 of the Code specifies that Tree Nuts are a food group and lists 16
different species of nuts. FSANZ also provides a user guide on Warning and Advisory Declarations,
which specifically exempts coconut from the term Tree Nuts as they are not considered to be
allergenic.
The Code defines Fish in Standard 2.2.3 as any of the cold-blooded aquatic vertebrates and aquatic
invertebrates such as shellfish or jellyfish, but does not include amphibians and reptiles. As the
Table to Clause 4 of Standard 1.2.3 specifically lists Crustacea and their products (i.e. prawns, crabs,
crayfish) these need to be specifically labelled for the purpose of the allergen statement, whereas
aquatic invertebrates are be adequately covered in the summary statement as Fish.
Standard 1.2.3 of the Code contains provisions for mandatory declarations, mandatory advisory
statements and mandatory prescribed statements, including warning statements. The Code
also specifies requirements for legibility under Standard 1.2.9, which sets out how the information
should be presented.
1.2
Food allergy symptoms vary in nature and severity between individuals and may include:
respiratory problems (rhinitis, asthma, throat swelling)
gastrointestinal problems (nausea, vomiting, diarrhoea, abdominal cramping) or
skin problems (hives, itching, dermatitis, eczema).
A severe reaction (anaphylaxis) can occur after contact/ingestion with allergens in foods. This
can result in a rapid loss of blood pressure, severe obstruction of the airways, a generalised shock
reaction and multiple organ failure. This can be fatal if not treated within minutes. While few
people with food allergies are at risk of such serious consequences, some deaths have occurred
following accidental ingestion of a food containing an allergen to which the individual is sensitive.
Coeliac disease is an autoimmune reaction to dietary gluten. Although Coeliac disease does not
result in anaphylaxis, it causes damage to the intestine reducing the ability to absorb nutrients.
Symptoms may appear at any time from early childhood to senior years. Treatment requires a strict,
life-long gluten-free diet to allow the intestine to recover and to avoid complications.
In contrast to food allergies, food intolerances are generally more common. Reactions are more
obviously dose-related, and include non-protein substances in foods. An intolerance reaction to a
food may have delayed symptoms, with no observable effect for several hours after eating the food.
There are no proven laboratory tests for food intolerances and diagnosis is through the use of an
elimination diet. Symptoms can range from mild to severe and may include:
hives, eczema, other itchy skin rashes
stuffy or runny nose, asthma, frequent colds or ear infections
mouth ulcers, reflux, bloating, stomach aches, constipation and / or diarrhoea, incontinence
migraines or headaches
lack of concentration, anxiety, depression, lethargy, irritability, sleeping difficulties.
3. Allergen Management
Many foods contain ingredients which are known allergens (listed under Section 1.1) and must be
labelled according to regulatory requirements in the Code. Food allergens can become part of a
food through unintended exposure. This may result from:
inadvertent presence in raw materials
processing aids (e.g. enzymes)
incorrect formulation
changes to product scheduling
rework
insufficient or ineffective cleaning/sanitation procedures
in-process cross contact
post-process contact.
The recommended approach to allergen risk management is through a Hazard Analysis and Critical
Control Point (HACCP) program. This involves evaluating the hazards associated with the whole
lifecycle of the product, starting with the production of raw materials and assessing every step of
the process through to labelling and packaging of the final product for consumption. The critical
points where allergens can be introduced into products during manufacture should be identified,
and a system established to monitor these critical control points, to ensure that unintentional cross
contact is minimised. The following sets out important areas for consideration, but this is not an
exhaustive list and other issues may need consideration depending on the situation.
Food Industry Guide to Allergen Management and Labelling - 2007 Revised Edition
3.1
3.2
Raw materials
Raw materials may contain allergens that are inadvertently present. This may occur at the suppliers
site prior to the ingredient reaching your plant or it may occur as a result of cross contact within
your manufacturing plant. Suppliers should have good allergen management practices to
minimise the risk of cross contact between raw materials.
Allergen information should be provided by the suppliers of each raw material to identify any
products that contain allergens, or that are derived from allergenic foods, or have a high likelihood
of cross contact with allergenic substances. While some ingredients are easily identified as
containing, or derived from, allergens, others are more difficult. It is essential that information is
provided by the supplier that verifies whether or not allergens are present. Any change to supplier
or suppliers source should trigger a review of allergen status.
Alternative ingredients should be treated like standard ingredients, with all information necessary
provided so the manufacturer can avoid unintentional introduction of allergenic raw materials,
or can take into account the need for allergen declarations for alternative ingredients when
developing labels.
The AFGC Food Industry Product Information Form (PIF) is available from the Allergen Bureau website
to help food companies obtain allergen information from their suppliers in a consistent manner.
This form requests information on the food allergens present in the raw material and the potential
for cross contact of the material.
Manufacturers should review the information collected on the PIF and consider the potential for
inadvertent presence of allergens in materials (see Section 6). Vendor audits can further explore the
potential for allergen cross contact.
3.3
Premises
The manufacturing plant, where possible, should be designed to assist in allergen management.
Manufacturers producing at more than one site might consider consolidation of products
containing like allergens to one location, or create sites free from specific allergens.
Separate production equipment and tools should be used to establish a clear distinction between
products containing different allergens and those that do not contain allergens.
3.4
3.5
Manufacturing process
To minimise the potential for unintentional allergen cross contact of product, allergen management
practices should be part of good manufacturing practices (GMP) and HACCP-based food safety
systems, and should be taken into account when these systems are audited.
When ingredients are selected for use in product manufacturing, the ingredients and their product
information should be checked against the design criteria to ensure they are suitable for the
product to be manufactured. Where possible, a production system should be designed to minimise
the potential for cross contact. Monitoring systems should be in place to ensure that cross contact
does not occur.
Manufacturers should use dedicated manufacturing tools or equipment for specific allergencontaining products to minimise any chance of cross contact. Production schedules should
be organised to process allergen free products at the beginning of the schedule, with allergen
containing products run at the end of the production schedule and followed immediately by the
cleaning cycle (see Section 3.9). Appropriate scheduling and longer runs can also minimise the
potential for allergen cross contact. Clearly defined allergen clean up procedures should be in
place on the manufacturing line and in the event of raw material spills.
3.6
Rework
Rework policies and procedures are required to minimise the risk of allergen cross contact. Rework
that contains allergenic ingredients should not be included in material that would otherwise
be free of that allergen. Rework should be clearly labelled so it can be identified. A procedure
for tracking rework through to a finished product is an important element of an allergen risk
management program.
Food Industry Guide to Allergen Management and Labelling - 2007 Revised Edition
3.7
3.8
3.9
Cleaning
Documented and validated cleaning procedures are critical for avoiding unintentional allergen
cross contact. Adequate time must be allowed for cleaning and verification. Re-cleaning may be
required if verification shows initial cleaning has not been adequate. Cleaning short-cuts could
lead to product build-up in the manufacturing equipment.
To ensure successful cleaning it is necessary to consider:
documented cleaning procedures
training of cleaning personnel and operators
knowledge of the system to identify hidden or static areas
knowledge of the allergen status of the products
effective cleaning equipment and supplies
dismantling equipment to remove allergen residues
cleaning verification e.g. visual inspection, sampling or testing for allergen residues
minimise use of air guns and water hoses to avoid distributing allergens within the plant.
3.10
5. Labelling
5.1
Food Industry Guide to Allergen Management and Labelling - 2007 Revised Edition
Standard 1.2.4 of the Code permits the declaration of alternative ingredients. Manufacturers may
occasionally substitute one ingredient for another within the same class of foods. The statement
of ingredients may list both ingredients in a way which makes it clear that alternative or substitute
ingredients are being declared. Where this involves a substance listed in the Table to clause 4 of the
Code there must be a declaration on the label that the allergenic substance is present in the food.
Labelling should clearly indicate that the product contains one substance or another (e.g. brazil
nuts or cashew nuts).
5.2
Industry responsibilities
Manufacturers need to be aware of the nature of the ingredients they use in their products, and
whether there are components in compound ingredients, additives and processing aids that may
be derived from an allergen. For example, additives, processing aids and vitamins are often mixed
with carriers or diluents derived from substances required to be declared. Suppliers of ingredients,
additives and processing aids have a responsibility to provide their customers with information on
allergens contained in their products.
The current requirement to label applies to any product derived from these allergens irrespective of
how highly refined or processed it may be. An example of a material that can be highly processed
is wheat, where labelling would apply equally to wheat flour, wheat starch, wheat maltodextrins,
glucose and caramel derived from wheat, or grain alcohol.
Manufacturers should assess the need for in-store demonstrators to provide consumer advice
about the presence of allergenic ingredients, as consumers often do not have the opportunity to
read the label before tasting the product. Consideration should be given to ensuring information is
also provided at external outlets in the convenience and trade routes.
5.3
5.4
10
5.5
Ingredients
Water, vegetable oil, vinegar, cane sugar, tomato paste (5%), salt, parmesan cheese (2%),
egg yolk, maize thickener (1412), almonds, red capsicum, soybean oil, garlic (1.0%),
vegetable gum (415), spice, herbs, wheat cornflour, flavour (wheat maltodextrin, sesame
oil), antioxidant (320).
Gluten source (grain source)
qualified in ingredient list.
Contains milk, egg, almonds, soy, wheat and sesame.
May be present: xxx.
Precautionary statement declared if
appropriate. This statement must only
be used in conjunction with VITAL.
Ingredient List
All allergens are identified in the ingredient list each time an ingredient containing an
allergen is listed.
Allergens are declared in bold type each time they appear in the ingredient list.
Gluten source (grain source) is qualified in the ingredient list at all times.
Declare in bolding the allergenic ingredient/component or qualify in bold the ingredient/
component according to the allergenic foods listed in the Table to clause 4 of Standard 1.2.3
in the Code. e.g. Parmesan cheese or Parmesan cheese (milk) .
Declare the specific name of the tree nut/s in the ingredient list when added as a direct
ingredient, rather than the generic term nuts or tree nuts.
Processing aids derived from an allergenic source must declare the allergen in the ingredient
list.
Food Industry Guide to Allergen Management and Labelling - 2007 Revised Edition
11
5.6
12
Water, vegetable oil, vinegar, cane sugar, tomato paste (5%), salt, parmesan cheese (2%),
egg yolk, maize thickener (1412), almonds, red capsicum, soybean oil, garlic (1.0%),
vegetable gum (415), spice, herbs, wheat cornflour, flavour (wheat maltodextrin, sesame
oil), antioxidant (320).
Gluten source (grain source)
qualified in ingredient list.
Contains milk, egg, almonds, soy, wheat and sesame.
May be present: xxx.
Precautionary statement declared if
appropriate. This statement must only
be used in conjunction with VITAL.
Water, vegetable oil, vinegar, cane sugar, tomato paste (5%), salt, parmesan cheese (2%)
(milk), egg yolk, maize thickener (1412), tree nuts (almonds), red capsicum, soybean
oil, garlic (1.0%), vegetable gum (415), spice, herbs, wheat cornflour, flavour (wheat
maltodextrin, sesame oil), antioxidant (320).
Gluten source (grain source)
qualified in ingredient list.
May be present: xxx.
Precautionary statement declared if
appropriate. This statement must only
be used in conjunction with VITAL.
Food Industry Guide to Allergen Management and Labelling - 2007 Revised Edition
13
6.1
VITAL
VITAL requires the assessment of likely sources of cross contact allergenic substances from raw
materials and the processing environment, an evaluation of the amount present, a review of the
ability to reduce the allergenic material from all contributing sources and ongoing monitoring and
verification. Particulate and readily dispersible materials are treated differently.
The Decision Tree is a schematic representation of the VITAL. The numbering in the Decision Tree
relates directly to the detailed VITAL procedure available from the Allergen Bureau website.
14
6.2
The VITAL cross contact statement should only be used where cross contact is:
documented using VITAL; and
unavoidable; and
sporadic.
Precautionary labelling should ONLY be used after a thorough risk assessment. Precautionary
statements must NEVER be used as a substitute for good manufacturing practice (GMP) or as
a generic disclaimer. Every attempt must be made to eliminate or minimise cross contact by
adhering to GMP.
Processing Impact
NO
NO
Particulate form
YES
YES
NO
precautionary
statement required.
NO
NO
NO
Action Level
2
Action Level
3
May be Present
statement required.
Ingredient
labelling required.
NO
precautionary
statement required.
15
March 2006
16
May 2007
www.afgc.org.au